Floatz Rating
BB64/100
Confidence
Indicative
Sponsor
East Metropolitan Health Service, Australia
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
56High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07651618CT.gov A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma | — | Not Yet Recruiting | — | — | — |
NCT07627698CT.gov Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma | — | Recruiting | — | — | — |
NCT07406724CT.gov HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma | — | Not Yet Recruiting | — | — | — |
NCT07410494CT.gov Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT04119024CT.gov Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors | — | Recruiting | — | — | — |
NCT06946225CT.gov ACTengine® IMA203 Combined With mRNA-4203 | — | Recruiting | — | — | — |
NCT06743126CT.gov SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma | — | Recruiting | — | — | — |
NCT06151847CT.gov Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma | — | Completed | — | — | — |
NCT05576077CT.gov A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors | — | Terminated | — | — | — |
NCT05628883CT.gov Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma | — | Completed | — | — | — |
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NCT05176470CT.gov Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients | — | Active Not Recruiting | — | — | — |
NCT05050006CT.gov ITIL-168 in Advanced Melanoma | — | Terminated | — | — | — |
NCT02652455CT.gov Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma | — | Completed | — | — | — |
NCT02500576CT.gov Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT01740557CT.gov Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma | — | Completed | — | — | — |
NCT01955460CT.gov Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma | — | Active Not Recruiting | — | — | — |
NCT01807182CT.gov Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT01271907CT.gov Drosophila-generated CTL | — | Terminated | — | — | — |
NCT01005537CT.gov Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma | — | No Longer Available | — | — | — |
NCT00704938CT.gov Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer | — | Terminated | — | — | — |
NCT00512889CT.gov Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma | — | Completed | — | — | — |
NCT00313508CT.gov Dendritic Cell Vaccination During Lymphoid Reconstruction | — | Completed | — | — | — |
NCT00324623CT.gov Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT00138229CT.gov Cyclophosphamide and Fludarabine Followed By an Autologous Lymphocyte Infusion and Interleukin-2 in Treating Patients With Refractory or Recurrent Metastatic Melanoma | — | Terminated | — | — | — |
NCT00096382CT.gov Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT00091104CT.gov Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT00091143CT.gov Fludarabine Followed by Vaccine Therapy and White Blood Cell Infusions in Treating Patients With Unresectable or Metastatic Melanoma | — | Completed | — | — | — |
NCT00085462CT.gov Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT00085423CT.gov Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT00079144CT.gov Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion, Peptide Vaccine Plus Montanide ISA-51, and Interleukin-2 in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT00062036CT.gov Cyclophosphamide and Fludarabine Followed By Interleukin-2 Gene-Modified Tumor Infiltrating Lymphocytes in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT00317759CT.gov Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma | — | Completed | — | — | — |
NCT00045357CT.gov Biological Therapy in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT00006233CT.gov Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma | — | Completed | — | — | — |
NCT00004135CT.gov Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer | — | Completed | — | — | — |
NCT00004022CT.gov Biological Therapy Following Surgery in Treating Patients With Stage III or Stage IV Melanoma | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
81High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Cutaneous Melanoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Fludarabine (this asset) | East Metropolitan Health Service, Australia | P3 | BB · 64 |
| Alpha-Interferon | MIPO Clinic | P3 | BBB |
| TIL | City of Hope Medical Center | P2 | BBB |
| Dacarbazine | Linnaeus Therapeutics, Inc. | P3 | BBB |
| Cis-Diamminedichloroplatinum Ii | MIPO Clinic | P3 | BBB |
| Tyrosinase Peptide | University of Southern California | P3 | BBB |
| Nivestim | Vastra Gotaland Region | P3 | BB |
| Multi-Epitope Melanoma Peptide Vaccine | Craig L Slingluff, Jr | P2 | BB |
| Mart-1 Antigen | Mayo Clinic | P2 | BB |
+42 more in the Cutaneous Melanoma cohort
Other indications for Fludarabine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Adult T-Cell Leukemia/Lymphoma | — | P2 | BBB · 76 |
| Acute Myeloid Leukemia With Abnormal Bone Marrow Eosinophils Inv(16)(P13q22) Or T(16;16)(P13;Q22) | — | P2 | BBB · 76 |
| Fanconi Anemia | — | P2/3 | BBB · 76 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Fludarabine in Cutaneous Melanoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/fludarabine-cutaneous-melanoma
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